Omni Instrument Tray

GUDID 15420045510296

Hologic, Inc.

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Primary Device ID	15420045510296
NIH Device Record Key	61c197b0-a93b-4e9e-92c5-a04bf7ac8903
Commercial Distribution Status	In Commercial Distribution
Brand Name	Omni Instrument Tray
Version Model Number	60-903
Company DUNS	018925968
Company Name	Hologic, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045510296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182052

FDA Product Code

KCT	Sterilization wrap containers, trays, cassettes & other accessories